HAMILTON-C2
FDA 510(k) clearance K121225 · decided 2012-11-16
Clearance details
- K-number
- K121225
- Device name
- HAMILTON-C2
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2012-04-23
- Decision date
- 2012-11-16
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonaduz, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adu recall (Z-2141-2023) | Hamilton Medical, Inc. | 2023-07-21 |
| HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; recall (Z-0170-2014) | Hamilton Medical, Inc. | 2013-11-06 |